Alerts
Liposyn II and Liposyn III (Hospira) - Recall of Additional Lots Due to Presence of Particulate Matter - UPDATE
June 11, 2010
Hospira initiated a voluntary recall of additional lots of Liposyn II, 10% and 20% strengths, and Liposyn III, 10%, 20% and 30% strengths. Lot numbers beginning with 72-78 and 82-85 are affected. Lot numbers beginning with 79 and 80 remain affected by the recall. All lot numbers were distributed from December 2008 to April 2010. The particulate matter appears to have originated from the stainless steel equipment used during manufacturing. Adverse events due to the presence of particulate matter have not been reported. However, there is the concern that the foreign particulate matter may cause serious adverse effects including restricted blood flow in the body and embolism. Do not use Liposyn II or Liposyn III from these affected lot numbers and quarantine the product. Return product from these lot numbers to Stericycle (866-654-0725). Report any adverse events to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf.
Additional information may be found at the following links:
- Medwatch Safety Alert:
- June 2010
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm215033.htm - Nov 2009
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm189589.htm - Press Release:
Updated
June 11, 2010; November 11, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
